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Please use this identifier to cite or link to this item: http://hdl.handle.net/123456789/16951

Title: Comparative bioavailability study of doxycycline hyclate (equivalent to 100 mg doxycycline) capsules (doxycin vs vibramycin) for bioequivalence evaluation in healthy adult volunteers
Authors: ); Al-Khamis, KI
Keywords: doxycycline; comparative bioavailability; doxycin; vibramycin; healthy volunteers
Issue Date: 2004
Publisher: DUSTRI-VERLAG DR KARL FEISTLE, BAJUWARENRING 4, D-82041 OBERHACHING, GERMANY
Abstract: This investigation was carried out to evaluate the bioavailability of a new capsule formulation of doxycycline (100 mg), doxycin, relative to the reference product, vibramycin (100 mg) capsules. The bioavailability was carried out in 24 healthy male volunteers who received a single dose (100 mg) of the test (A) and the reference (13) products after an overnight fast of at I east 10 hours on 2 treatment days. The treatment periods were separated by a 2-week washout period. A randomized, balanced 2-way crossover design was used. After dosing, serial blood samples were collected for a period of 48 hours. Plasma concentrations of doxycycline were analyzed by a sensitive and validated high-performance liquid chromatography assay. The pharmacokinetic parameters for doxycycline were determined using standard noncompartmental methods. The parameters AUC(0-t), AUC(0-infinity), C-max K-el, t(1/2) and C-max/AUC(0-infinity) were analyzed statistically using log-transformed data. The time to maximum concentration (t(max)) was analyzed using raw data. The parametric 90% confidence intervals of the mean values of the pharmacokinetic parameters: AUC(0-t), AUC(0-infinity), C-max and C-max/AUC(0-infinity) were within the range 80 - 125% which is acceptable for bioequivalence (using log-transformed data). The calculated 90% confidence intervals based on the ANOVA analysis of the mean test/reference ratios of AUC(0-t), AUC(0-infinity), C-max and C-max/AUC(0-infinity) wcre 95.98 - 109.56%, 92.21 to 107.66%, 93.90 - 112.56%, and 96.0 to 106.91% respectively. The test formulation was found bioequivalent to the reference formulation with regard to AUC(0-t), AUC(0-infinity), C-max and C-max/AUC(0-infinity) by the Schuirmann's two l-sided t-tests. Therefore, the 2 formulations were considered to be bioequivalent.
URI: http://hdl.handle.net/123456789/16951
Appears in Collections:College of Pharmacy

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